Liaoning early warning: 42 drugs due to API pressure can not be normal supply!

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On July 23, Liaoning Province's centralized procurement network for drugs and medical consumables issued the ''Notice of Liaoning Province's No. 2 Early Warning and Forecast of Drugs in Shortage of 2018 ''(hereinafter referred to as the ''Notice''), which pointed out that according to the data reported by Liaoning Province's drug shortage monitoring and early warning and supply guarantee system and drug shortage monitoring sentinel, the province reported 325 drug shortage information from April to June 2018, and initiated investigation procedures for 81 drugs that could not be normally supplied and distributed.

It is worth noting that the survey results show that: 12 drugs have insufficient production capacity due to raw materials, enterprise production line transformation and other reasons; 13 drugs have stopped production due to the lack of raw materials; 17 drugs have increased the price of raw materials and low bid prices. Can not be supplied normally.

It is not difficult to see that the core reasons why the supply of the above 42 drugs cannot be guaranteed are all related to the inability to normally purchase bulk drugs, specifically including lidocaine hydrochloride injection, calcium gluconate injection, nitroglycerin injection and other bulk drug price increases that have been widely discussed in the industry before. The enterprises involve China Resources Shuanghe, Beijing Yimin, Guoyao Rongsheng, Lukong Medicine, etc.

 Insufficient production capacity due to raw materials, enterprise production line transformation and other reasons (12)

 Discontinued due to lack of raw materials (13)

  Rising prices of APIs and low winning prices (17)

  Raw material drug prices rose fiercely, preparation companies feel pressure

On July 2, the "Pharmaceutical Economic News" WeChat published "Another API price increase of 50 times! Fear of hundreds of billions of drug market" article, the disclosure of chlorpheniramine maleate (chlorpheniramine) API quotation has soared from 260 yuan to 280 yuan/kg at the end of last year to 15000 yuan/kg, causing concern and heated discussion in the industry.

In fact, the huge fluctuations in the prices of some APIs have caused the price of preparations to rise. Oryzanol, vitamins, amiodarone hydrochloride, anisodamine injection, nitroglycerin injection, moxifloxacin, allopurinol, dextran glucose injection, cedilanid, dopamine and many other varieties, especially essential drugs and low-cost drugs, have seen significant price increases in recent years.

According to industry insiders, since the second half of 2017, the prices of some raw materials have risen fiercely. "The price of several vitamin varieties has risen from the original tens of yuan/kg to 100 or 200 yuan/kg; preparations are also rising, nitroglycerin injection from 10 yuan/box (10 sticks), has risen to 150 yuan to 200 yuan/box (10 sticks). Injection products basically more than 100 kinds of raw materials, many of which have market monopolies."

The huge increase in the cost of upstream API is obviously an important reason for the difficulty of sustained and stable supply of downstream preparations. According to the analysis of the early warning catalogue issued by Liaoning's "notice", 36 of the 42 products are injections and powder injections, which is obviously in line with the judgment of the above-mentioned industry insiders.

"Exclusive production, control of supply, price skyrocketing." This basic API monopoly path is well known to the industry. In November last year, the National Development and Reform Commission also issued my country's first "Guidelines for the Price Behavior of Operators of Shortage Drugs and APIs" to check the monopoly of APIs. The whole industry chain has abhorred the unreasonable rise in the cost of APIs and the monopoly of the related varieties of the market.

However, the China Pharmaceutical Enterprise Management Association found in a survey that the price of some APIs with the highest increase is still rising to 70 times in less than two years. Under the pressure of rising costs, the industry still seems unable to find a breakthrough to directly solve the problem, and preparation companies feel that it is difficult to survive in the process of rising upstream costs and downstream bidding.

Some varieties of joint price adjustment in recent years (incomplete statistics)

  The problem of monopoly price increase of raw materials needs to be solved urgently.

Liaoning this "notice" to the normal supply of drugs enterprises also put forward clear measures:

Suspend the corresponding drug transactions of the 13 production enterprises that have stopped production due to the lack of raw materials. After the production enterprises can normally produce and supply, they can apply for the resumption of online procurement;

Shanghai Xudong Haipu Pharmaceutical Co., Ltd., Jiangsu Shengdi Pharmaceutical Co., Ltd., Shanghai Hefeng Pharmaceutical Co., Ltd., Jiangsu Yabang Epson Pharmaceutical Co., Ltd., Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., Tonghua Dongbao Pharmaceutical Co., Ltd., Shandong Lukang Pharmaceutical Group Saite Co., Ltd., Shandong Qidu Pharmaceutical Co., Ltd., Shandong Hualu Pharmaceutical Co., Ltd., Jilin Cornell Pharmaceutical Co., Ltd. and other 10 pharmaceutical manufacturers were warned.;

Serious warnings were given to four pharmaceutical manufacturers, including Tianjin Jinyao Pharmaceutical Co., Ltd., Suicheng Pharmaceutical Co., Ltd., Kaifeng Pharmaceutical (Group) Co., Ltd., and Hebei Jianning Pharmaceutical Co., Ltd., which have been warned. Rectification measures were proposed for the above-mentioned 14 pharmaceutical manufacturers within a time limit of one month, and the rectification situation was reported to the Office of the Leading Group for the Centralized Procurement of Drugs and Medical Consumables in Medical Institutions in Liaoning Province. Failure to rectify within the time limit was included in the bad record of pharmaceutical purchase and sales in Liaoning Province.

Ensuring drug supply, straightening out drug prices, and stabilizing market order have become the focus of drug administration work at this stage. Curbing illegal price increases and malicious control of sales has a very prominent significance in the context of pharmaceutical system reform. Due to the shortage of drugs and APIs, there is a natural scarcity and widespread demand, which has become a high incidence of illegal prices, profiteering and unfair competition.

Since 2011, the national price authorities have successively investigated and dealt with a number of shortage drugs such as promethazine hydrochloride, allopurinol tablets, estazolam, isoniazid and other drug shortages and price monopolies implemented by API operators. Experts said frankly: "In the past, drug regulation and market supervision were fragmented, and the crackdown on API monopoly was insufficient. After the institutional reform, the drug regulatory authorities and market regulatory authorities merged, unified into the whole process of market supervision ideas can focus on solving some key problems, the problem of API monopoly price increases is the top priority to be solved."